Adipose-tissue-derived Total-Stromal-cells (TOST) Therapy in Knee Osteoarthritis

NCT05280002 | Completed Phase 2 DMC

• 1 other identifier: BSMMU/2018/25
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

In this phase II Randomized Clinical Trial (RCT), impacts of a single Intra-articular injection of autologous adipose tissue derive total-stromal-cells (TOST) on knee pain, physical function, stiffness, and cartilage thickness assessed and compared changes before and after intervention. Individuals with knee osteoarthritis (KOA) diagnosed by using the American College of Rheumatology (ACR) criteria for Osteoarthritis knee were included in the study. Kellgren-Lawrence (KL) radiological scores were used to define radiological changes and high-frequency musculoskeletal ultrasonogram (MSUS) was used to measure cartilage thickness.

Conditions

Osteoarthritis Knees

Keywords

Osteoarthritis, Adipose Tissue, TOST, Stem Cell

Outcome Measures

Primary Outcomes (3)

• Changes in pain intensity

  Changes in pain intensity are assessed from baseline and at week 4, 12, and 24 using Visual Analogue scale (VAS) \[0-10 cm scale\], where score '0' denotes no pain and 10 means worst pain.

  Before treatment and after treatment at week 4, 12, and 24

• Changes in Physical functioning of knee joints.

  Changes in Physical functioning of knee joints were measured by The Western Ontario and McMaster Universities Arthritis Index (WOMAC). There are 17 items consist in WOMAC physical function such as Physical Function (17 items): using stairs, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy domestic duties, light domestic duties. Each item is scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). The WOMAC physical score ranges between 0 and 68. The lower score means better knee functioning.

  Before treatment and after treatment at week 4, 12, and 24

• Changes in femoral cartilage thickness

  Changes in cartilage thickness was measured from baseline to 24 weeks of the study period using high frequency ultrasound 15 MHz (6-15 MHz) transducer (Samsung Accuvix, 2010, South Korea). Mean femoral cartilage was considered for analysis

  Baseline and 24 weeks after treatment

Study Arms (2)

Adipose Tissue derived Total-Stromal-Cells (TOST)

EXPERIMENTAL

Adipose Tissue derived Total-Stromal-Cells (TOST) containing mesenchymal stem cells plus standard conservative care.

Biological: Adipose Tissue derived Total-Stromal-Cells (TOST)

Control

NO INTERVENTION

Standard Conventional Treatment

Interventions

Adipose Tissue derived Total-Stromal-Cells (TOST) BIOLOGICAL

Single dose autologous aAdipose Tissue derived Total-Stromal-Cells (TOST) containing mesenchymal stem cell was injected in each knee of the participants having knee osteoarthritis.

Adipose Tissue derived Total-Stromal-Cells (TOST)

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Primary KOA with KL-grade II and III radiological changes

You may not qualify if:

• KOA received IA steroid, viscosupplementation, or PRP injection or undergone knee surgery within the last six months.
• Patients with septic and tubercular arthritis, post-traumatic hemarthrosis, unstable knee joint due to anterior cruciate ligament (ACL) injury, malignancy, autoinflammatory arthritis (gout), inflammatory disease (rheumatoid arthritis, psoriatic arthritis, reactive, and ankylosing spondylitis), and charcot arthropathy.
• Patients with local eczematous skin and skin infection

Sponsors & Collaborators

• Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh: lead
• Dhaka Medical College: collaborator

Study Sites (1)

Bangabandhu Sheikh Mujib Medical University

Dhaka, Bangladesh

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Moshiur Rahman Khasru, MBBS, FCPS

  Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Both clinical and high-frequency-ultrasound-scanning Assessors were blinded about the case and control.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 24, 2022
• First Posted: March 15, 2022
• Study Start: January 1, 2018
• Primary Completion: October 31, 2021
• Study Completion: December 31, 2021
• Last Updated: March 15, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1)